Botulinum Toxin Study

Botulinum Toxin Study
New York City

Date: Fri, 12 May 2000
Subject: As you requested- Raw Data Botox(R)

Dear Jack:

As you requested, here is the very preliminary Raw data on the first 11 study participants: we had 9 of 11 fissures heal. Nitroglycerin did not appear to enhance the healing rate but the small numbers we have analyzed and completed to date will not reach statistical significance. Subjects 12-16 are currently in the treatment phases and were not included in the analysis. Three patients were not included in the study for exclusion criteria.

I would add the caveat again, That this is very preliminary early raw data and one should be careful in applying it to all situations. Once the study data is completed then statiscal methods will be applied to dtermine the actual benefits.

The study is still accrueing patients and will not be completed unitl August 2000. See the Clinical Watch posting: Study Posting (1069) -- Trial #19040, Anal Fissures, New York City, NY for information on participating in the study.

David m. Feldman, M.D.
Principal Investigator
Saint Vincents Hospital Medical Center
New York City

Date: Fri, 3 Mar 2000
Subject: Update Botox Study United States
To: jack

Dear Jack:

The response to your posting of my study for Botox (R) for anal fissures has been overwhelming. I have responded to a large number of queries from throughout the United States, Canada and Europe. Also, several anal fissure sufferers from the Midwest and Southeast have come to us in New York City for entry into the study. I am also very pleased by the early preliminary results of this study.

To encourage dissemination of Botox(R) information and for future participants in this important study, I ask that you update interested sufferers of anal fissures with this information. And encourage people to enter controlled study trials, so that we can determine how best to treat the sufferers of disorder.

Here is some information about Botox(R):

  • A recent report in the New England Journal (July 1999) from Italy, showed a 96% cure rate for Chronic Anal Fissures. Original Articles -- NEJM 1999; 341: 65-69 using Botox(R)
  • Botox has only been evaluated for use in Chronic Anal Fissures. Chronic fissures are those fissures that have been present more than six weeks and have certain characteristics that can be found on examination.
  • Botox has not been approved by the FDA for usage in the anal canal. It is possible that with further study of the medication, the FDA could receive a request to approve it for usage in the anal canal. That is why studies are important to determine the efficacy so that Botox may eventually be approved for this usage. Botox can be used outside of clinical trials but the medication is expensive and unlikely to be reimbursed at the current time by insurance plans.
  • To be eligible for this study you must have a chronic fissure with the typical features found on examination of the anal area and must not have used nitroglycerin for 3 months or had prior anal surgery. Participants in the study receive all medications in the study free of charge.
  • The injection of Botox is done in one session and causes only mild discomfort. It is unlikely that any after effects would occur. If you are determined to be eligible for entry into the study, You will be asked to sign a consent form which will outline all the possible benefits and possible adverse reactions. This study has been approved by the local hospital Institutional Review Board(IRB). Although Botox is the most potent toxin known to mankind, The pharmaceutical purified diluted toxin for human use, is remarkably free of side effects when used locally in the anal area.

    I hope this information is useful to you.

    David Feldman, MD
    Investigator, Botox Study
    Saint Vincent's Hospital Medical Center of New York
    Clinical Instructor, New York Medical College

    Date: Sat, 4 Sep 1999 13:41:23 EDT
    Subject: Botox study USA
    To: jack

    Dear Jack,

    Really great and valuable information resource you have assembled on the web.I am quite impressed with the plethora of valuable information.

    I am a New York City Gastroenterologist interested in treating diseases of the Anus, including Anal Fissures. Most of the time Anal Fissures are treated by Surgeons who have a tendency to perform surgery. I do not perform surgery and therefore, I am involved in attempting to cure without surgery. My current research project, for which I have a grant, is to study treatment of fissures with Botulinum toxin (BOTOX). I am currently putting together a presentation for my research project On Botox for Treatment of Chronic Anal Fissures. Which is how I came across your web site.

    As you probably have come to realize the anal area has often been ignored by the medical doctors and many patients suffer in embarassement. The pharmaceutical companies on the other hand have recognized this as a very large market. And this accounts for the many over the counter remedies. Albeit with unproven efficacy. The unfortunate and timely demise of Proctology as a bonafide specialty has further led to the decline in interest in the medical community.

    I believe there exists a renewed interest in this important, although not lifethreatening condition. As evidenced by the lead article in the New England Journal of Medicine- July 8, 1999 A comparasion of Nitroglycerin and Botulinum to treat anal fissures. This study was from Italy.

    If anyone is in interested in participating in my US study using Botox and nitroglycerin, I am still recruiting patients. They can contact me at or 888-391-9532

    David Feldman MD
    Principal Investigator Botulinum Toxin for Anal Fissures
    Section of Gastroenterology

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